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NCT01120184 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,095
- Enrollment target
NCT01120184 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,095 participants.
The verdict
NCT01120184, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,095 participants
- Enrollment target
Study Summary
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
Interventions
- DRUG docetaxel
- DRUG paclitaxel
- DRUG pertuzumab
- DRUG pertuzumab-placebo
- DRUG trastuzumab [Herceptin]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,095 participants |
| Start Date | 2010-07-31 |
| Est. Completion | 2016-09-16 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01120184
The ClinicalTrials.gov registry entry for NCT01120184 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,095 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which docetaxel is the first listed.
NCT01120184 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01120184 about?
NCT01120184 is a clinical study titled "A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)". This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or p...
What is the current status of trial NCT01120184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,095 participants. The study started on 2010-07-31. Estimated completion is 2016-09-16.
What interventions are being tested in trial NCT01120184?
The interventions under investigation include: docetaxel (DRUG), paclitaxel (DRUG), pertuzumab (DRUG), pertuzumab-placebo (DRUG), trastuzumab [Herceptin] (DRUG).
Who is sponsoring clinical trial NCT01120184?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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